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Important Disclaimer
These statements have not been evaluated by the Food and Drug Administration (FDA). Compounded products are not FDA-approved and are not intended to diagnose, treat, cure, or prevent any disease. Individual results may vary. The information provided is for educational purposes only and should not be considered medical advice. Always consult with your healthcare provider before starting any new treatment.
Clinical Information
Evidence-based details for healthcare providers
Use only by a licensed healthcare practitioner as part of an in-office procedure and according to your facility protocol and the instructions for use (IFU). Do not attempt to use this kit on yourself. If any item is damaged, opened, or not sterile, do not use it and replace the kit.
This product is a procedural supply kit, not a medication, so it does not work through chemical action in the body. The trocar and obturators are mechanical tools used to help create a controlled pathway under the skin so a practitioner can place a pellet as part of a medical procedure. The benefit patients may notice is related to the procedure itself (such as a shorter procedure time and fewer instrument changes) rather than any drug effect. Any effects occur during the procedure and end once the instruments are removed.
Do not use if any package is opened, torn, wet, or past the expiration date because sterility may be lost. Do not use if the patient has a known allergy or sensitivity to any kit components (for example, adhesives used in dressings or benzoin tincture), as this may cause a skin reaction. Do not use for patients or procedures that are not appropriate for trocar-based insertion as determined by the licensed healthcare practitioner. Do not reuse single-use items because this can increase the risk of infection, tissue injury, or device failure.
This kit does not contain medication, so it does not have drug-drug interactions. However, some included items may affect patient care: compound benzoin tincture and adhesives may increase skin irritation when used with topical acne medicines, retinoids, or steroid creams on the same area. Alcohol-based skin preps can further dry or irritate skin if the patient is using other drying skin products. Patients taking blood thinners (such as warfarin, apixaban, rivaroxaban, clopidogrel, or aspirin) may have higher bleeding or bruising risk from the procedure; the prescriber should review these medicines before the procedure.
This kit is a set of supplies, not a drug, so side effects are mainly related to the procedure and skin contact materials. Common: temporary pain, tenderness, swelling, bruising, bleeding, or redness at the insertion site; these often improve over a few days. Uncommon: skin irritation or rash from tape, transparent dressings, alcohol prep, or benzoin tincture; remove the irritant and contact your healthcare provider if it worsens. Rare but serious: infection (increasing redness, warmth, pus, fever), severe bleeding, fainting, or severe allergic reaction (hives, swelling of face or throat, trouble breathing); seek urgent medical care right away.
Store at room temperature (68-77 degrees F / 20-25 degrees C) in a clean, dry area. Protect from moisture, direct sunlight, and extreme heat or cold. Keep the kit sealed in its original packaging until time of use to help maintain sterility. Do not use if the sterile barrier is damaged or if the kit is expired. Dispose of used sharps (needles, scalpel, trocar/obturators) right away in an FDA-cleared sharps container; dispose of other contaminated waste per your facility policy and local rules.
Frequently Asked Questions
Is this kit sterile and latex-free?
The kit is intended to be sterile and includes a sterile tray and latex-free items as listed. Always check the outer packaging for intact seals and an expiration date before use. If the package is torn, wet, or open, do not use the kit.
What is the difference between the 3.5 mm and 4.5 mm trocar kits?
The main difference is the size of the trocar device and matching obturators. A practitioner may choose 3.5 millimeter for smaller pellets and 4.5 millimeter for larger pellets based on the procedure plan. Your clinician will select the size that fits your treatment.
Can I use this kit at home or on myself?
No. This kit is meant for use by trained, licensed healthcare professionals in a controlled setting. Using it at home can cause serious harm, including infection, bleeding, and nerve injury.
What should I watch for after the procedure?
Mild soreness, bruising, or a small amount of bleeding can happen and often improves in a few days. Call your healthcare provider if you have increasing pain, redness, warmth, swelling, pus, a bad smell, or fever. Get urgent care right away for heavy bleeding, fainting, or trouble breathing.
Do any items in the kit contain medicine?
The kit includes supplies that may be used during a procedure, including skin prep and a small vial of compound benzoin tincture to help tape stick. It does not include the pellet medication itself. Your clinician will provide any prescribed medication separately.
How should used needles and the scalpel be thrown away?
All sharps must go into an FDA-cleared sharps container right after use. Do not throw sharps into household trash or recycling. Follow your facility policy and local rules for disposal of biohazard waste.
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